Status:
COMPLETED
Heterosubtypic Immune Responses to Influenza in Older People
Lead Sponsor:
University Hospitals, Leicester
Collaborating Sponsors:
Centers for Disease Control and Prevention
Public Health England
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Vaccination is the principal means of combating epidemic and pandemic influenza. As vaccines induce relatively strain-specific and short-lived antibody responses, annual immunisation with regularly up...
Detailed Description
STUDY OBJECTIVES: Immunological objectives * To evaluate heterosubtypic neutralising antibody to influenza viruses in older people * To evaluate heterosubtypic neutralising antibody responses to hum...
Eligibility Criteria
Inclusion
- Subjects aged over 18 years of age, mentally competent, who have signed an informed consent form after having received a detailed explanation of the study protocol;
- Subjects willing to be enrolled in the vaccine study if appropriate from prescreening blood test results
- In good health as determined by:
- medical history,
- physical examination,
- clinical judgment of the Investigator;
- Able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for study visits
Exclusion
- Receipt of another investigational agent within 4 weeks, or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another clinical study through the end of the study;
- Subjects who experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) within the past 7 days before Visit 1 or any visit where trial vaccination is planned;
- Subjects who experienced fever (within 3 days prior to Visit 1;
- Subjects who are pregnant or breastfeeding;
- Females of childbearing potential who refuse to use an acceptable method of birth control for the duration of the study.
- Subjects with any serious disease, such as:
- cancer,
- autoimmune disease (including rheumatoid arthritis),
- progressive chronic pulmonary disease (stable controlled respiratory disease including asthma is allowed),
- acute or progressive hepatic disease,
- acute or progressive renal disease;
- Subjects for whom elective surgery is planned during the study period;
- Subjects with bleeding diathesis;
- Subjects with hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine;
- Subjects with a history of any neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
- Subjects with known or suspected impairment/alteration of immune function, for example, resulting from:
- receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy),
- receipt of immunostimulants,
- receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study,
- high risk for developing an immunocompromising disease;
- Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination;
- Subjects with a history of (or current) drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of study objectives;
- Subjects with any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
- \-
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
292 Patients enrolled
Trial Details
Trial ID
NCT00798343
Start Date
January 1 2009
End Date
September 1 2013
Last Update
June 3 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospitals Leicester
Leicester, Leicestershire, United Kingdom, LE1 5WW